Innovative Strategies For Risk Reduction Following CABG
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|ClinicalTrials.gov Identifier: NCT00462436|
Recruitment Status : Completed
First Posted : April 19, 2007
Last Update Posted : July 22, 2010
Background: Treatment targets for cardiac risk factor reduction are not being met. Therefore, there is a need for new strategies to assist patients in meeting these goals.
Objective: To determine the amount of any additional benefit on risk factor reduction associated with the consumption of the "dietary portfolio" (a low fat diet with soy, nuts and viscous fibres), above that achieved with medical management in diabetic patients following cardiac surgery.
Description: 35 cardiac surgery patients with diabetes will be instructed on how to incorporate the dietary portfolio foods into their diet for four weeks. Changes in blood cholesterol, markers of inflammation, blood sugar control and modifiable risk factors will be assessed after 2 and 4 weeks of therapy.
Relevance: Maximizing cardiac risk factor reduction through a combined approach (dietary plus medication) should improve outcomes, reduce rates of re-hospitalization and improve quality of life in diabetic patients after heart surgery.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Type II Diabetes Mellitus||Behavioral: Consumption of Dietary Portfolio||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Do Innovative Strategies Complement Medical Management to Reduce Cardiovascular Risk Factors Following Coronary Artery Bypass Graft Surgery?|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||May 2010|
- Behavioral: Consumption of Dietary Portfolio
The study involves following an aggressive low fat diet that is high in viscous fiber, nuts and soy protein. The diet is individually tailored to meet individual participants needs.
- Primary Outcome: Reduction of total and LDL cholesterol [ Time Frame: baseline to 4 weeks ]
- Improvement in endothelial function and EPC counts [ Time Frame: Baseline to 4 weeks ]
- Reduction in CRP [ Time Frame: baseline to 4 weeks ]
- Feasibility and tolerability [ Time Frame: Baseline to 4 Weeks ]
- Reduction in markers of inflammation ie TNF, IL-6 [ Time Frame: Baseline to 4 weeks ]
- Improved markers of glycemic control - fructosamine, HOMA [ Time Frame: baseline to 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00462436
|St. Michael's Hospital|
|Toronto, Ontario, Canada, M5B 1W8|
|Principal Investigator:||Mary Keith, PhD, RD||St. Michael's Hospital, Toronto|